Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Co-Plavix
Active Ingredients: Aspirin 100mg
Clopidogrel bisulfate, form II equivalent to 75mg clopidogrel
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Winthrop Industrie, Carbon Blanc Cedex, France
Product: Fentanyl
Active Ingredient: Fentanyl citrate 78.5µg/mL equivalent to 50µg/mL fentanyl
Dosage Form: Solution for injection
New Zealand Sponsor: Boucher & Muir New Zealand Limited t/a Goldshield Healthcare (New Zealand)
Manufacturer: B Braun Melsungen AG, Berlin, Germany
Product: Finaccord
Active Ingredient: Finasteride 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Finaccord
Active Ingredient: Finasteride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Helixate NexGen
Active Ingredient: Octocog alfa 2000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Healthcare LLC, California, United States of America
Product: Lamivudine 150mg Zidovudine 300mg Alphapharm
Active Ingredients: Lamivudine 150mg
Zidovudine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashta State, India
Product: Lipitor
Active Ingredient: Atorvastatin calcium 10.85mg equivalent to 10mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Godecke GmbH, Freiburg, Germany
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Product: Lipitor
Active Ingredient: Atorvastatin calcium 21.7mg equivalent to 20mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Godecke GmbH, Freiburg, Germany
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Product: Lipitor
Active Ingredient: Atorvastatin calcium 43.4mg equivalent to 40mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Godecke GmbH, Freiburg, Germany
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Product: Lipitor
Active Ingredient: Atorvastatin calcium 86.8mg equivalent to 80mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Godecke GmbH, Freiburg, Germany
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Product: Lostaar
Active Ingredient: Losartan potassium 12.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashta State, India
Product: Lostaar
Active Ingredient: Losartan potassium 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashta State, India
Product: Lostaar
Active Ingredient: Losartan potassium 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashta State, India
Product: Lostaar
Active Ingredient: Losartan potassium 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashta State, India
Product: Sativex
Active Ingredients: Cannabidiol 27mg/mL as Cannabis sativa extract 36mg-44mg
Tetrahydrocannabinol 25mg/mL as Cannabis sativa extract 35mg-42mg
Dosage Form: Oral spray
New Zealand Sponsor: Health Support Limited
Manufacturer: CP Pharmaceuticals Limited, Wrexham, United Kingdom
Product: Temaccord
Active Ingredient: Temozolomide 5mg
Dosage Form: Capsule
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Temaccord
Active Ingredient: Temozolomide 20mg
Dosage Form: Capsule
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Temaccord
Active Ingredient: Temozolomide 100mg
Dosage Form: Capsule
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Temaccord
Active Ingredient: Temozolomide 140mg
Dosage Form: Capsule
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Temaccord
Active Ingredient: Temozolomide 180mg
Dosage Form: Capsule
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Temaccord
Active Ingredient: Temozolomide 250mg
Dosage Form: Capsule
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Tolteccord
Active Ingredient: Tolterodine tartrate 1mg equivalent to tolterodine 0.68mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Tolteccord
Active Ingredient: Tolterodine tartrate 2mg equivalent to tolterodine 1.37mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Zarator
Active Ingredient: Atorvastatin calcium 10.85mg equivalent to 10mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Godecke GmbH, Freiburg, Germany
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Product: Zarator
Active Ingredient: Atorvastatin calcium 21.7mg equivalent to 20mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Godecke GmbH, Freiburg, Germany
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Product: Zarator
Active Ingredient: Atorvastatin calcium 86.8mg equivalent to 80mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Godecke GmbH, Freiburg, Germany
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Product: Zarator
Active Ingredient: Atorvastatin calcium 43.4mg equivalent to 40mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Godecke GmbH, Freiburg, Germany
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Dated this 22nd day of October 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).